Kornimate/medical-research-clean huggingface dataset:
detection of microorganisms and antibiotic resistance genes using the curetis unyvero lrt55 application

Conditions: Pneumonia

Summary: the curetis unyvero lrt55 application is intended to detect and to identify genes of 21 microorganisms and 19 genes associated with antibiotic resistance in 4 hours. in this study, the performance of the unyvero lrt55 application shall be tested under clinical conditions and compared to (1) a composite reference method (for non-atypical or cultured microorganisms) or (2) a molecular pcr based reference method for the 3 atypical microorganisms chlamydophila pneumoniae, legionella pneumoniae, and pneumocystis jirovecii, and for resistance genes. pcr amplifications are followed by bi-directional sequencing, including comparison of the test results time to result will be compared for the unyvero lrt55 application and standard-of care.

this is a non-interventional, controlled, non-randomized multicenter clinical study that compares a new diagnostic device, the unyvero lrt55 application (based on molecular diagnostic methods) to either (1) a composite reference method (for non-atypical microorganisms), (2) a composite pcr-based method for 3 atypical microorganisms or (3) a pcr-based reference method for resistance genes. the study will use leftover lower respiratory tract samples taken from subjects suspected with lower respiratory tract infections: (a) specimens taken prospectively for standard-of-care (i.e. microbiology testing) from hospitalized subjects. (b) banked specimens for rare microorganisms. as the device is under investigation, the test results provided by the unyvero lrt55 application will not be made available to the treating physician and therefore will not be used for diagnosis, treatment or other management decisions.

Eligibility criteria:
inclusion criteria: * hospitalized subjects with suspicion of lower respiratory tract infection * age at least 18 years * available surplus respiratory aspirate or bronchial lavage sample exclusion criteria: * out-patient (ambulatory patient) * known infection with hiv, hbv or tuberculosis
fall prevention in older adults with oab

Conditions: Overactive Bladder

Summary: though oab treatment may improve physical activity, there is a lack of easily administered instruments for measuring physical activity in older adults. aim is to validate instruments to measure physical activity and preference for medication, and to determine the effect of preference for anti-cholinergic medication on adherence, physical activity, and falls risk. it's plan a prospective cohort study of adults aged 65 or older with oab undergoing treatment with anti-cholinergic medication.

older adults with overactive bladder (oab) have reduced physical activity and are at increased risk for falls. though recent studies suggest that treatment of oab may improve physical activity, there is a lack of easily administered instruments for measuring physical activity in older adults. furthermore, physical activity outcomes in older adults with oab are affected by treatment preference and potential neurocognitive dysfunction caused by anti-cholinergic medication. the aims of the present proposal are 1) to validate an instrument to measure physical activity 2) to validate an instrument to measure preference for medication and 3) to determine the effect of preference for anti-cholinergic medication on adherence, physical activity, and falls risk. plan: a prospective cohort study of adults aged 65 or older with oab undergoing treatment with anti-cholinergic medication. the primary outcome will be physical activity measured using a self-reported instrument and accelerometer at baseline and 8 weeks after treatment. secondary outcomes will be fall risk defined by changes in neurocognitive testing, urinary symptoms, and medication adherence at 8 weeks after treatment. the findings of this study could provide a paradigm shift in the management of older adults with oab and at increased risk for falls.

Eligibility criteria:
inclusion criteria: adults aged 65 or older, urinary urgency of quite a bit severity or more on the overactive bladder questionnaire-short form (oabq-sf), eligible for pharmacologic therapy for overactive bladder exclusion criteria: predominant stress incontinence (on udi-6), current/recent use (6 m) or contraindication to anti-cholinergic medication, severe voiding difficulties, men on 5-alpha reductase inhibitors, severe neurologic disease, recent anti-incontinence or prolapse surgery, other urinary tract conditions such as calculus or recurrent uti.
at278, novorapid® and humulin® r (u500) in glucose clamp study

Conditions: Diabetes Mellitus, Type 2

Summary: this is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart at278 (u500/ml) with standard insulin aspart novorapid® (u100/ml) in participants with t2d. participants and investigators will be blinded to both study interventions. humulin® r u-500 (u500/ml), a highly concentrated regular human insulin, will be used as an open-label comparator.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes for at least 180 days prior to the day of screening * haemoglobin a1c (hba1c) concentration of ≤9.5% (≤80 mmol/mol) at screening. * bmi within the range of 25 - 45 kg/m2 (both inclusive) exclusion criteria: * known or suspected hypersensitivity to imps or related products * clinically significant concomitant disease or abnormal lab values * severe asthma or chronic obstructive pulmonary disease (gold iii and iv), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists
assessment of intraocular pressure (iop) control in subjects with open-angle glaucoma or ocular hypertension treated with travoprost 0.004% (travatan® z) or bimatoprost 0.01% (lumigan®)

Conditions: Glaucoma; Ocular Hypertension; Open-Angle Glaucoma

Summary: the purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of open-angle glaucoma (oag) or ocular hypertension (oht) in at least one eye. * non-study eye: intraocular pressure (iop) able to be controlled with no pharmacologic therapy or on the study medicine alone. * willing to discontinue the use of all other ocular hypotensive medications prior to receiving study medication and for the entire course of the study. * able to follow instructions, self instill study article, and attend all study visits. * best-corrected snellen visual acuity of 20/200 or better in each eye. * sign ethics committee reviewed and approved informed consent form. * other protocol-defined inclusion criteria may apply. exclusion criteria: * known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations used in this study. * any abnormality preventing applanation tonometry in either eye. * dry eye previously or currently being treated with punctal plugs, punctal cautery, restasis®, or topical ocular corticosteroids. * concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. * intraocular conventional or laser surgery \>3 months prior to consent. * risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. * progressive retinal or optic nerve disease from any cause. * use of any systemic medications known to affect iop which have not been on a stable course for at least 7 days prior to screening or an anticipated change in dosage during the course of the study. * any clinically significant, serious, or severe medical condition. * women of childbearing potential who are pregnant, lactating, or not using reliable means of birth control. * participation in any other study within 30 days prior to screening. * use of any systemic (oral), injectable or topical steroids. * other protocol-defined exclusion criteria may apply.

Keywords: glaucoma ocular hypertension open-angle glaucoma intraocular pressure
the effects of iron treatment on malaria and measles vaccine response in kenyan infants with iron deficiency

Conditions: Iron Deficiencies

Summary: malaria and iron deficiency cause a significant burden of disease in africa. iron deficiency (id) might affect immune responses to vaccination. in this double-blind randomized controlled trial, we aim to assess: (1) whether id impairs r21/matrix-m and measles (mr) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.


Eligibility criteria:
inclusion criteria: * subject's caregiver is willing and able to give informed consent * male or female, 6 months (+/- 2 weeks) of age * mother at least ≥15 years of age * iron deficient (erythrocyte zinc protoporphyrin (znpp) \>61 μmol/mol heme) * with or without anemia (anemia defined by hb \<110 g/l) exclusion criteria: * severely anemic (hb \<70 g/l) * malaria vaccination prior to enrollment * medical condition that precludes study involvement * iron supplementation 2 weeks before enrollment * acute or chronic infection (e.g. hiv) * wasted (length for height z score of ≥-2) or underweight (weight for age z score ≥-2).

Keywords: iron deficiency vaccine immunogenicity malaria measles
needle radiofrequency treatment for submental fat

Conditions: Obese

Summary: the investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.


Eligibility criteria:
inclusion criteria: * patients with excess submental fat on a grade of 1\~4, as assessed by the physician-assisted submental fat rating scale exclusion criteria: * mental impairment, infectious disease * history of keloid development * pregnancy, pacemaker * use of anticoagulants * undergoing a facelift procedure within the prior 6 months.
knee registry (knieregister)

Conditions: Knee Pathology; Osteoarthritis, Knee; Osteochondritis Dissecans; Chondral Defect; Osteochondral Defect

Summary: rationale: in view of patient care, patient characteristics and treatment parameters are registered for all patients visiting the mobility clinic of the university medical center utrecht for orthopaedic knee treatment. patients also fill out questionnaires for function, pain and mobility of the knee, before and after treatment. objective: the main objective of this registry is to collect patient characteristics and treatment parameters together with data from the questionnaires in a database. this knee registry can be used for future research questions. study design: this is a longitudinal observational registry. study population: all patients that visit the mobility clinic will be asked to participate in the knee registry. patients that meet one or more of the following criteria will be excluded: are below the age of 16, not able or willing to sign the broad consent form, not being able to read and understand dutch language, or receiving medical treatment for their knee elsewhere. main study parameters/endpoints: data will be collected for future research for which the purpose is not known at this time. when new research will be conducted, study parameters will be set. a study application has to be submitted to the institutional ethical review board of the university medical center utrecht. patients do not need to be asked permission for the use of their data for each study individually. only when additional information is needed. nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden for patients to participate in this registry is minimal and consists of time. any future results may be beneficial for patients. participation or refusal to participate in the registry has no consequences for their treatment.


Eligibility criteria:
inclusion criteria: * receives orthopaedic knee surgery or conservative knee treatment (advice, physiotherapy, injections etc) at the umc utrecht; * able to read and understand dutch language; * is able and willing to signs the broad consent form. exclusion criteria: * receives no treatment (refusal of surgery or treatment); * receives treatment elsewhere.

Keywords: knee
strengthening skills behavioral intervention for adults with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to examine changes in adaptive functioning, quality of life, and prospective memory among adults with asd (autism spectrum disorder) who complete strengthening skills, a multi-faceted, behavioral intervention that combines the peers social skills program with cognitive compensation training, mindfulness-based emotional regulation, and support group components. participants and their study partners (e.g., spouse, parent, friend) will be randomly assigned to one of three groups: strengthening skills, peers only, or a delayed treatment control group. the strengthening skills group will meet weekly for 3 hours for 16 weeks and will learn strategies for gaining and maintaining independence and emotion regulation. participants will also learn strategies from the peers social skills program. the peers only group will meet weekly for 1.5 hours for 16 weeks and will only learn strategies from the peers social skills program. the delayed treatment control group will participant in data collection at four time points over a 10-month wait period, after which, they will be enrolled into the strengthening skills program. behavioral self-report data will be collected and a prospective memory assessment will be conducted before and after participation in the 16-week programs. behavioral self-report data will also be collected at remote 3- and 6-month follow-up visits.


Eligibility criteria:
inclusion criteria: * meets criteria for autism or autism spectrum on a gold-standard diagnostic assessment (autism diagnostic observation schedule-2) * must have a study partner (e.g., parent, spouse, sibling, friend) willing and able to complete questionnaires at all four time points * must be willing to be randomized to a treatment or delayed treatment control group * must be able to attend at least 14 of the 16 weekly intervention sessions * english speaking: participants must be english-speaking because the screening and behavioral measures are in english (including the intelligence estimate), as well as the intervention content exclusion criteria: * non-verbal participants will be excluded to ensure test compliance and increase sample homogeneity. * participants with iq (intelligence quotient) scores lower than 70 will be excluded because the interventions were developed for individuals without intellectual disability.
clinimacs® cd34+ reagent system for expanded access use

Conditions: Graft-Versus-Host Disease(GVHD); Anemia Due to Disturbance of Proliferation and/or Differentiation of Hematopoietic Stem Cells; Graft Failure; Delayed Graft Function

Summary: clinimacs is an investigational device used to select and enrich stem cells. the device will select the stem cells with cd34+ protein. the participant will be infused with the cd34+ selected cells in the hopes that it will help the participant engraft. engraftment is when transplanted stem cells resume production of healthy blood cells.

* after the screening procedures confirm that the participant is eligible to participate in the research study: if the participant takes part in this research study, the participant (and their donor) will have the following tests and procedures: * donor graft collection: the participant's cell donor will undergo stem cell collection. the cells collected will be sent to the laboratory for processing. * donor graft processing: in the laboratory the clinimacs device will be used to separate the cd34+ stem cells from the other types of cells in the graft. after completing the necessary safety tests, the cd34+ selected donor graft will be ready for administration. * donor graft infusion: the cd34+ selected donor graft will be infused through an intravenous (i.v.) catheter. the day of this infusion is called day 0. * follow-up visits: approximately 3, 6 and 12 months after the donor graft infusion, the participant will return to clinic for follow-up visits. at each of the visits, the participant will have a physical exam and asked questions about your general health. the participant will also have routine blood tests performed (approximately 1 tablespoon of blood). * at times more cells are collected from a donation than are needed to do the transplantation. if your physician determines that it is preferable to administer a dose of cells that is less than the complete collection, the extra cells may be frozen and stored in our freezers for the participant's future use. if the cell counts do not improve, the participant will be given the remaining cells through an intravenous (i.v.) catheter.

Eligibility criteria:
inclusion criteria: * patients aged \>18 years * diagnosis is graft exhaustion. * ability to understand and willingness to sign a written informed consent document * matched related or unrelated donor must consent to provide an allograft. exclusion criteria: * symptomatic or uncontrolled cardiac failure or coronary artery disease. * karnofsky performance status \< 60%.

Keywords: graft-versus-host disease(gvhd) hematopoietic stem cell transplantation. graft failure graft exhaustion
laparoendoscopic rendez vous versus standard two stage approach for the management of cholelithiasis/choledocholithiasis

Conditions: Choledocholithiasis; Cholelithiasis

Summary: the purpose of the study is to assess whether combined intraoperative ercp and cbd clearance with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach) is or not superior to the standard practice of preoperative ercp, sphincterotomy and cbd clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with combined cholelithiasis and choledocholithiasis.

the ideal management of concomitant cholelithiasis and choledocholithiasis is not known yet. there are several options, including one-stage or two-stage approaches. the most commonly used practice is the two-stage management which consists of preoperative ercp, sphincterotomy and cbd clearance followed by laparoscopic cholecystectomy. however, with this approach, a number of patients will be submitted to an unnecessary ercp while some others will develop complications, mainly pancreatitis due to inadvertent pancreatic duct cannulation. laparo-endoscopic rendez-vous methods have been described in order to obtain selective cbd cannulation and omit the risk of post-ercp pancreatitis. in this procedure, during laparoscopic cholecystectomy, a wire is inserted through the cystic duct into the common bile duct, advanced into the duodenum where is found endoscopically, gripped with a snare and retrieved through the mouth. the a sphincterotome is inserted over the wire and elective cbd cannulation is obtained to be followed by sphincterotomy and cbd clearance intraoperatively. the method has been described by several authors in small to moderate case series, its safety has been proven and it appears that reduces both the length of hospital stay and the incidence of post-ercp pancreatitis.however, it has not been popularized and has never been tested over the standard two-stage management. in our hospital, the standard approach for cholelithiasis and choledocholithiasis has been, as well, the two-stage (preop ercp and sphincterotomy followed by laparoscopic cholecystectomy)approach. we initially assessed the feasibility and safety of the laparo-endoscopic rendez vous with a pilot study and now we intend to compare the two methods in a prospective randomized trial.

Eligibility criteria:
inclusion criteria: * patients must be able to give informed consent preoperatively * asa i-iii * patients at high risk to have cbd stones (jaundice, cholangitis, grossly deranged lfts, cbd stones found on us or mrcp) exclusion criteria: * patients not fit for surgery (asa iv) * previous ercp and sphincterotomy * previous upper abdominal surgery * pregnancy at time of surgery
childhood trauma and escape decision dynamics

Conditions: Child Abuse; Fear

Summary: the purpose of this study is to evaluate the effects of childhood maltreatment on cognitive and reactive fear.

childhood maltreatment dramatically increases the risk for psychiatric disorders accompanied by profound difficulties in social interactions. however, it is still unclear how childhood maltreatment affects social interactions in adulthood. in this study, we examine how childhood maltreatment may modulate threat sensitivity assessed by the distance at which an individual flees from an approaching threat. while rapid escape decisions rely on "reactive fear" circuits, slower escape decisions are associated with "cognitive fear" circuits. based on previous observations of altered early sensory processing, we expect that childhood maltreatment affects both cognitive and reactive fear circuits.

Eligibility criteria:
inclusion criteria: * healthy subjects with varying levels of childhood maltreatment exclusion criteria: * current psychiatric illness * current psychiatric medication or psychotherapy * mri contraindication (e.g. metal in body, claustrophobia) * pregnancy

Keywords: cognitive fear fmri reactive fear
upper endoscopy in cirrhotic patients with upper gastrointestinal bleeding

Conditions: Esophageal Varices

Summary: liver cirrhosis is a common diffuse and persistent liver disease often accompanied by portal hypertension, liver failure, upper gastrointestinal bleeding (ugib), and other complications. the incidence rate of liver cirrhosis with ugib is as high as 30-40%, which is related to the rupture bleeding of gastroesophageal varices (gov), hepatogenic ulcer, portal hypertensive gastropathy, hepatic gastrointestinal failure, etc

in the case of ugib in patients with liver cirrhosis, acute peripheral circulatory failure may suddenly occur, resulting in decreased blood perfusion in liver tissues, often accompanied by clinical manifestations such as blood volume decline, melena, and haematemesis. this disease progresses rapidly, with a mortality rate of above 10% if not treated promptly timing of endoscopy in the management of acute upper gastrointestinal bleeding (augib) has been a subject of perennial debate. despite remarkable advancements in endoscopic treatments and substantial efforts in reducing mortality, the overall in-hospital mortality rate associated with ugib is still estimated to be 10%. several studies have investigated the clinical impact of urgent (within 6 h of presentation) or early (within 12 h) endoscopy on mortality in patients with ugib. some studies showed no significant difference in mortality rate between urgent and elective endoscopy groups among high-risk patients with acute ugib in contrast, others found that urgent endoscopy was associated with a lower mortality rate in high-risk patients with acute non-variceal ugib. most of the previous studies included highly selected patients with non-variceal ugib or those at a high risk. however, given that the definitive diagnosis is made after endoscopic examination, these studies may not reflect real-world clinical practice. furthermore, it is often challenging to predict the cause of bleeding and to identify patients at high risk who require intensive care based on their symptoms and the information obtained in the emergency room

Eligibility criteria:
inclusion criteria: any patient who is above age of 18 years old and with liver cirrhosis and present with ugib will be eligible for the study exclusion criteria: * patients with age less than 18 years old * non-cirrhotic patients * patients with hemodynamic instability * patient's refusal